Skip to main content
OpenTrials
Completed

NCT Number: NCT03847883

Low-dose Versus Standard Dose Alteplase in Acute Ischemic Stroke , 4 Monthes Prospective Study

Cohort A Randomized Control trial of Ateplase 0.6, 0.75 and 0.9 mg/kg in 78 patients Cohort B single arm 0.9 mg/kg Ateplase in 330 patients Combined Cohort A and B evaluate different of death, intra-cerebral hemorrhage, numberof patient with mRS 0-1 at discharge and 3 months follow up, and other important stroke outcomes

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assistant Professor Subsai Kongsaengdao

Bangkok, 10400, Thailand

About this study

We conducted the prospective study to compare the low-dose and standard-dose rtPa and identify the important factors predicted stroke outcomes in acute stroke patient received intravenous rtPa. In Cohort A, During 2011-2012, 78 patients were randomly assigned to received intravenous rtPa 0.6 mg/kg , 0.75 mg/Kg, or 0.9 mg/Kg (1:1:1). After interim analysis during 2012-2017, in Cohort B, 330 patients were assigned to receive standard-dose rtPa 0.9 mg/kg. The good outcomes were defined as improvement of modified Rankin scale (mRS) by final score 0-1 or improvement > 4 points at discharge or 3 months follow up, absent of intracranial hemorrhage within 36 hours treatment, 90-day post-stroke survival , and short hospital length of stay.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Acute ischemic stroke
  • Age 18 to 80 years
  • Onset of stroke symptoms with in 4.5 hours before initiation of study-drug administration
  • Stroke symptoms present for at least 30 minutes with no significant improvement before treatment

Exclusion criteria

  • patients with Intracranial hemorrhage
  • the symptoms of Time onset was unknown
  • Symptoms rapidly improving or only minor before start of infusion
  • Seizure at the onset of stroke
  • Stroke or serious head trauma within the previous 3 months
  • Administration of heparin within the 48 hours preceding the onset of stroke, with an activate
  • partial-thromboplastin time at presentation exceeding the upper limit of the normal range
  • Platelet count of less than 100,000 per cubic millimeter
  • Systole pressure greater than 185 mm Hg or diastole pressure greater than 110 mm Hg, or aggressive treatment intravenous medication) necessary to reduce blood pressure to these limits
  • Blood glucose less than 50 mg per deciliter or greater than 400 mg per deciliter
  • Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal
  • Oral anticoagulant treatment
  • Major surgery or severe trauma within the previous 3 months
  • Other major disorders associated with an increased risk of bleeding

Treatment and study plan

Intravenous Solution Ateplase

Drug

Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke

Primary outcomes

  1. Death in 36 hours

    Time frame: 0-36 hours

    Number of patient die in 36 hours

  2. Death in 3 months

    Time frame: 0-3 months

    Number of patient die in 3 months

  3. Death in 4 months

    Time frame: 0-4 months

    Number of patient die in 4 months

  4. Total number of patients with mRS 0-1 at discharged

    Time frame: 1day to <3 months

    Number of patients with mRS 0-1 at discharge 1day to 3 months interval

  5. Total number of patients with mRS 0-1 at 3 months

    Time frame: At 3 months

    Number of patients with mRS 0-1 at 3 months

  6. Number of patients with All intra-cerebral hemorrhage (ICH) at 36 hours

    Time frame: 0- 36 hours

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  7. Number of patients with All intra-cerebral hemorrhage (ICH) at 3 months

    Time frame: 0-3 months

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  8. Number of patients with All Intra-cerebral hemorrhage (ICH) at 4months

    Time frame: 0-4 months

    Total Intracerebral hemorrhage (ICH) including both Symptomatic ICH , and Asymptomatic ICH

  9. Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 36 hours

    Time frame: 0-36 hours

    Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration

  10. Number of patients with Symptomatic Intra-cerebral hemorrhage (ICH) at 4 months

    Time frame: 0-4 months

    Total Number of patients with Symptomatic ICH need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration

  11. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 36 hours

    Time frame: 0-36 hours

    Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration

  12. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 3 months

    Time frame: 0-3 months

    Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration

  13. Number of patients with Asymptomatic Intra-cerebral hemorrhage (ICH) 4 months

    Time frame: 0-4 months

    Total Number of patients with Asymptomatic ICH wich no need emergency surgery craniotomy or Venticulostomy drainaged or other management to reduce intracranial pressure such as intubation with mechanical ventilator or hyperosmolar drug administration

Secondary outcomes

  1. Good stroke outcomes

    Time frame: 0-4 months

    Total number of patients with "good outcomes" were defined as number of patients with this any one item criteria

    • improvement of modified Rankin scale (mRS) by final score 0-1
    • mRS improvement > 4 points at discharge or 3 months follow up, And must full fill all of this criteria
    • absent of intracranial hemorrhage within 36 hours treatment and 2) survive at 90-day post-stroke ,and 3) short hospital length of stay less than 7 days

  2. Improved mRS at discharge

    Time frame: (At discharge) 1 day to 3 months

    Number of patients with improve mRS after treatment at least 1 Score

  3. Improved mRS 3 months

    Time frame: At 3 months

    Number of patients with improve mRS after treatment at least 1 Score

  4. Number of patienta with Length of hospital stay (LOS) less than 7 days Days

    Time frame: 1- 7 days

    Number of patients with LOS < 7 days ( patients must survive )

  5. All complications

    Time frame: 0-4 months

    Number of patients with stroke complications after treatment

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Collaborators

  • Lumpang Hospital

Registry information

Official study title

Low-dose Versus Standard-dose Ateplase in Acute Ischemic Stroke ; A 4 Months Prospective Randomized Control Pilot Follow by Single Arm Standard Dose Ateplase Study.

Important dates

Study start
2011
Primary completion
2018
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.